Sr I, Associate Quality Control

About This Role:

As a Sr. Quality Control Analyst, you will play a pivotal role in supporting the Quality Control team within our QC Lab. This position is integral to ensuring both functional and operational excellence, helping to drive quality initiatives that align with regulatory standards. You will lead equipment and instrument qualification, software validation, and in-country testing for release and method validation. Your expertise in validation documents and protocols will support the lifecycle of laboratory instrumentation, ensuring compliance with data integrity principles and site procedures. As a key member of the lab operations, you'll collaborate with international Quality Control groups and various departments to manage change control activities and deploy compliance improvements. Your leadership will also extend to guiding the team through audits, inspections, and site-wide initiatives, ensuring the consistent delivery of top-quality results.

What You'll Do:

• Lead equipment and instrument qualification, as well as software validation projects.
• Perform in-country testing for release and method validation.
• Ensure lab adherence to company policies and GMP, as well as Health and local authority requirements.
• Author and oversee validation and qualification protocols and reports.
• Manage the lifecycle of systems and instrumentation in compliance with data integrity principles.
• Interface with international Quality Control groups and facility validation teams.
• Conduct advanced Methods Transfers, including executing, editing, and approving protocols and reports.
• Act as a project leader, collaborating with Quality, Regulatory, and Analytical Development departments.
• Conduct impact assessments related to compliance and manage deviations, CAPA, and change control.
• Represent QC during audits and inspections, contributing to site-wide initiatives.
• Provide mentorship and training to colleagues.
• Be available for travel as needed.

Who You Are:

You are an analytical expert with a strong passion for quality control and assurance. Your keen attention to detail and commitment to compliance drive your success in navigating complex regulatory environments. You thrive in collaborative settings, bringing effective communication and leadership skills to every project. Your ability to manage multiple tasks and prioritize conflicting demands sets you apart, making you an invaluable asset to the team. You are proactive, self-motivated, and ready to lead initiatives that uphold the highest quality standards.

Required Skills:

• Bachelor's degree in Pharmacy (mandatory)
• Minimum of 6 years of experience in Quality Control or similar roles in the Pharmaceutical, Chemical, or Cosmetic industries
• Advanced proficiency in English (speaking, reading, and writing)
• Intermediate proficiency in Spanish (speaking, reading, and writing)
• Specialist in analytical instrumentation
• Strong oral and written communication skills
• Experience providing mentorship and training to colleagues
• Strong knowledge of GxP environments regulated by national and international authorities

Preferred Skills:

• Experience with microbiology testing
• Proven ability to lead projects independently and effectively interact with management

Job Level: Professional

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.